Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT02207088|
Recruitment Status : Completed
First Posted : August 1, 2014
Results First Posted : November 9, 2017
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Hepatitis C Virus Compensated Cirrhosis Severe Renal Impairment End-stage Renal Disease||Drug: ombitasvir/paritaprevir/ritonavir Drug: dasabuvir Drug: Ribavirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-I)|
|Actual Study Start Date :||September 23, 2014|
|Actual Primary Completion Date :||December 6, 2016|
|Actual Study Completion Date :||December 6, 2016|
Experimental: 3-DAA (Direct Acting Antivirals) with or without RBV
3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
Other Name: ABT-333
Other Name: RBV
- Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment [ Time Frame: 12 weeks after the last actual dose of study drug ]SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.
- Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 24 weeks ]On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.
- Percentage of Participants With Post-Treatment Relapse [ Time Frame: Within 12 weeks after the last dose of study drug ]Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207088
|Study Director:||Eric Cohen, MD||AbbVie|